Cleared Traditional

K965137 - FOGARTY VALVULOTOME MODEL 700091

K965137 is an FDA 510(k) clearance for FOGARTY VALVULOTOME MODEL 700091, manufactured by Baxter Edwards. The device is a Class 2 Cardiovascular device with product code MGZ cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K965137 · Baxter Edwards · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
163d
Days
Class 2
Risk

K965137 is an FDA 510(k) clearance for the FOGARTY VALVULOTOME MODEL 700091. Classified as Valvulotome (product code MGZ), Class II - Special Controls.

Submitted by Baxter Edwards (Irvine, US). The FDA issued a Cleared decision on June 4, 1997 after a review of 163 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4885 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Edwards devices

FDA 510(k) Submission Details - K965137

510(k) Number K965137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date June 04, 1997
Days to Decision 163 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MGZ Device Classification - Class 2, Special Controls

Product Code MGZ Valvulotome
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4885
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MGZ Valvulotome

All 16
Devices cleared under the same product code (MGZ) and FDA review panel - the closest regulatory comparables to K965137.
VALVULOTOME BY KOVEN
K080178 · Koven Technology, Inc. · Jul 2008
FOGARTY VALVULOTOME, MODEL 700091
K001734 · Edwards Lifesciences, LLC · Mar 2001
2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)
K980723 · Vascutech, Inc. · Feb 1999
URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS
K930011 · Uresil Corp. · May 1993
SCANLAN/TAHERI VALVULOTOME
K911184 · Scanlan Intl., Inc. · Feb 1992
OLYMPUS RETRACTABLE VALVULOTOME
K911702 · Olympus Corp. · Dec 1991